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LY3832479

Phase 1

Healthy | Small molecule | Other |Eli Lilly and Company|Last Updated: Dec 6, 2021

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials2
Total Enrollment44
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT04611789A Study of LY3832479 (LY-CoV016) in Healthy Participants 1PHASE1 COMPLETED 18Nov 2, 2020Feb 10, 2021Dec 6, 20211 United States
NCT04441931A Study of LY3832479 (LY-CoV016) in Healthy ParticipantsPHASE1 COMPLETED 26Jun 19, 2020Oct 2, 2020Dec 6, 20211 United States
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Study Endpoints
Primary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Tlast (AUC[0-tlast]) of LY3832479
Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose

Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve from Time 0 to tlast (AUC\[0-tlast\]) of LY3832479.

PK: Maximum Serum Concentration (Cmax) of LY3832479
Day 1, 2, 3, 4, 5, 6, 7, 15, 29, 60 and 85 postdose

PK: Maximum Serum Concentration (Cmax) of LY3832479.

Number of Participants With One or More Serious Adverse Event(s) (SAEs) Considered by the Investigator to be Related to Study Drug
Baseline through Follow-up (Week 12)

The number of participants with 1 or more SAEs assessed as related to the study drug and is summarized cumulatively. A serious adverse event is defined as an event that results in death, initial or prolonged hospitalization, is life-threatening, leads to persistent or significant disability/incapacity, is associated with congenital anomaly/birth defect, or is considered significant by the investigator for any other reason. A summary of all SAE's, regardless of causality, is located in the Reported Adverse Events section.

Secondary Endpoints
Pharmacokinetics (PK): Area Under the Concentration Versus Time Curve From Time 0 to Infinity (AUC[0-∞]) of LY3832479
Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
PK: Maximum Serum Concentration (Cmax) of LY3832479
Day 1 (predose, end of infusion, 6 hours after start of infusion), 2, 3, 8, 15, 29, 43, 57, 85
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
LY3832479EXPERIMENTALParticipants received single subcutaneous dose of 350 milligrams (mg) and 1000 mg LY3832479.
PlaceboPLACEBO_COMPARATORParticipants received single subcutaneous dose of Placebo.
Interventions
NameTypeDescription
LY3832479DRUGAdministered subcutaneously
PlaceboDRUGAdministered subcutaneously
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Are overtly healthy as determined by medical evaluation including medical history and physical examination * Are willing to follow study procedures, including having nasal or nasopharyngeal swabs collected * Have a body mass index (BMI) within the range of greater than or equa...

Countries:United States
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